A new era in prostate cancer treatment may be on the horizon as FutureChem, a Korean radiopharmaceutical leader, unveils compelling phase 2 clinical trial results for its innovative therapy, FC705. The drug, designed to target metastatic castration-resistant prostate cancer (mCRPC), has demonstrated superior therapeutic effects compared to Novartis’ Pluvicto, the current standard in radioligand therapy, potentially offering new hope for patients battling this aggressive disease.

FC705, labeled with lutetium-177, achieved a remarkable 60.0% response rate in PSMA-PET imaging for both soft-tissue and bone metastases, according to FutureChem’s phase 2 data.
This metric, which reflects tumor shrinkage, significantly outstrips Pluvicto’s 29.8% soft-tissue response rate, as measured by RECIST v1.1 criteria. The difference highlights FC705’s ability to more effectively target and reduce cancerous lesions, a critical factor for patients with advanced mCRPC, where cancer often spreads to bones and soft tissues.

Beyond tumor reduction, FC705 also excelled in reducing prostate-specific antigen (PSA) levels, a key biomarker for prostate cancer progression. The therapy achieved a best PSA 50 response—indicating at least a 50% reduction in PSA levels—in 73.3% of patients. In contrast, Pluvicto recorded a PSA 50 response in 46.0% of patients, underscoring FC705’s stronger impact on disease control.
Safety profiles between the two drugs are comparable, though FC705 reported a slightly higher rate of serious adverse drug reactions (ADRs) at 10.0%, compared to Pluvicto’s 9.3%.  The company argues that the reduced dosage, combined with an albumin binder that extends the drug’s circulation time, enhances its precision in targeting cancer cells while maintaining a manageable safety profile.
The trial’s success has propelled FC705 into the next stage of development. the company has submitted an Investigational New Drug (IND) application for phase 3 trials to South Korea’s Ministry of Food and Drug Safety, aiming to compare FC705 plus standard therapy against standard therapy alone. The drug’s orphan drug designation also positions it for potential conditional approval upon phase 3 authorization, which could accelerate its availability to patients. Meanwhile, FutureChem has initiate phase 2a trials in the U.S., signaling its ambition to compete on a global stage.

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